CompletedNCT01168973Updated Sep 25, 2019Results posted

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

A Phase 3 interventional study of Ramucirumab and Placebo (for Ramucirumab) in Non-Small Cell Lung Cancer, sponsored by Eli Lilly and Company. Completed at 231 sites in 27 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,253
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

Conditions studied

Non-Small Cell Lung Cancer

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Keywords

second line
non small cell lung cancer
NSCLC
phase 3
ramucirumab
lung cancer
docetaxel
taxotere

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 1,253 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy
Prior bevacizumab as first-line and/or maintenance therapy is allowed
Signed informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Histologically or cytologically confirmed NSCLC
Stage IV NSCLC disease
Participants have measurable or nonmeasurable disease
Adequate organ function, defined as:
- Total bilirubin less than or equal to Upper Limit of Normal (ULN),
- Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases,
- Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 50 milliliters per minute (ml/min) (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection),
- Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10\^3/microliters (µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dL), and platelets greater than or equal to 100 x 10\^3/µL,
- Adequate coagulation function as defined by International Normalized Ratio (INR) less than or equal to 1.5, or prothrombin time and partial thromboplastin time less than or equal to 1.5 x ULN.
- The participant does not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
Urinary protein is less than or equal to 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria greater than or equal to 2+, a 24-hour urine must be collected and must demonstrate less than 1000 milligrams (mg) of protein.
Participants of reproductive potential (both sexes) must agree to use reliable method of birth control (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy
Life expectancy of greater than or equal to 3 months
Prior radiation therapy is allowed if: In the case of chest radiotherapy at least 28 days have elapsed from the completion of radiation treatment prior to randomization; In the case of focal or palliative radiation treatment at least 7 days have elapsed from last radiation treatment prior to randomization (and provided that 25% or less of total bone marrow had been irradiated); In the case of Central Nervous System (CNS) radiation at least 14 days have elapsed from the completion of radiation treatment prior to randomization

Exclusion criteria

Exclusion Criteria:

Disease progression on more than 1 prior chemotherapy regimens
Participants whose only prior treatment was a tyrosine kinase inhibitor
The participant's tumor wholly or partially contains small cell lung cancer
Major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months.
Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy
Last dose of bevacizumab must be at least 28 days from time of randomization
Last dose of cytotoxic chemotherapy must be at least 14 days from time of randomization
The participant has untreated CNS metastases. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment Magnetic Resonance Imaging (MRI) or IV contrast Computed Tomography (CT) scan.
Radiologically documented evidence of major blood vessel invasion or encasement by cancer
Radiographic evidence of intratumor cavitation
History of uncontrolled hereditary or acquired thrombotic disorder
Chronic therapy with nonsteroidal anti-inflammatory drug (NSAIDs) or other antiplatelet agents; Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted
History of gross hemoptysis (defined as bright red blood or greater than or equal to 1/2 teaspoon) within 2 months prior to randomization
Clinically relevant congestive heart failure [New York Heart Association (NYHA II-IV)] or symptomatic or poorly controlled cardiac arrhythmia
Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization
Uncontrolled arterial hypertension greater than or equal to 150 / greater than or equal to 90 millimeters of mercury (mm Hg) despite standard medical management
Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
Significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding within 3 months prior to randomization
Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to randomization
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
Peripheral neuropathy greater than or equal to Grade 2 [National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.02]
Serious illness or medical condition(s) including, but not limited to: Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness; Active or uncontrolled clinically serious infection; Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Known allergy or hypersensitivity reaction to any of the treatment components
The participant is pregnant or breastfeeding
Current or recent (within 28 days prior to randomization) treatment with an investigational drug or device that has not received regulatory approval for any indication at the time of randomization, or participation in another interventional clinical trial
Prior therapy with docetaxel

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,253 participants (actual)

Study arms

Experimental
Ramucirumab + Docetaxel
Biological: Ramucirumab · Drug: Docetaxel
Placebo comparator
Placebo + Docetaxel
Drug: Placebo (for Ramucirumab) · Drug: Docetaxel

Interventions

BiologicalRamucirumab
10 milligrams per kilogram (mg/kg) administered intravenously (IV) on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Also known as: IMC 1121B, LY3009806
DrugPlacebo (for Ramucirumab)
Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
DrugDocetaxel
75 milligrams per square meter (mg/m\^2) (60 mg/m\^2 for the countries of Korea and Taiwan only with protocol amendment dated 22 May 2012) administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

What researchers measure

Primary outcomes

Overall Survival
Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.
Time frame: Randomization to date of death from any cause (up to 34 months)

Secondary outcomes

Progression-Free Survival (PFS) Time
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Time frame: Randomization to measured PD or date of death from any cause (up to 29 months)
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.
Time frame: Baseline to measured PD (up to 29 months)
Percentage of Participants Achieving Disease Control (Disease Control Rate)
Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)\*100.
Time frame: Baseline to measured PD (up to 29 months)
Maximum Improvement on Lung Cancer Symptom Scale (LCSS)
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.
Time frame: Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores
The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab
Time frame: Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)
Number of Participants With Anti-Ramucirumab Antibodies
The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.
Time frame: Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Other outcomes

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died
Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time frame: First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Results

Posted Dec 29, 2014

Limitations and caveats

Three participants randomized to placebo and docetaxel received 1 dose of ramucirumab in error. They are included in the placebo and docetaxel arm in the ITT population and are included in the ramucirumab and docetaxel arm in the Safety population.

Participant flow

Participant flow — Overall Study
Milestone	Ramucirumab and Docetaxel	Placebo and Docetaxel
Started	628	625
Received any quantity of any study drug	624	621
Completed	15	14
Not completed	613	611
Withdrew: Progressive disease	341	429
Withdrew: Adverse event	94	55
Withdrew: Withdrawal by subject	90	53
Withdrew: Death	42	45
Withdrew: Physician decision	37	19
Withdrew: Sponsor decision	2	1
Withdrew: Protocol criterion not met and deviation	7	9

Outcome measures

PrimaryOverall Survival

Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.

Time frame:: Randomization to date of death from any cause (up to 34 months)
Reported as:: Median · months

Overall Survival
months	Ramucirumab and Docetaxel	Placebo and Docetaxel
Overall Survival	10.5 (9.5 to 11.2)	9.1 (8.4 to 10.0)

SecondaryProgression-Free Survival (PFS) Time

PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.

Time frame:: Randomization to measured PD or date of death from any cause (up to 29 months)
Reported as:: Median · months

Progression-Free Survival (PFS) Time
months	Ramucirumab and Docetaxel	Placebo and Docetaxel
Progression-Free Survival (PFS) Time	4.5 (4.2 to 5.3)	3.0 (2.8 to 3.9)

SecondaryPercentage of Participants Achieving an Objective Response (Objective Response Rate)

Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.

Time frame:: Baseline to measured PD (up to 29 months)
Reported as:: Number · percentage of participants

Percentage of Participants Achieving an Objective Response (Objective Response Rate)
percentage of participants	Ramucirumab and Docetaxel	Placebo and Docetaxel
Percentage of Participants Achieving an Objective Response (Objective Response Rate)	22.9 (19.7 to 26.4)	13.6 (11.0 to 16.5)

SecondaryPercentage of Participants Achieving Disease Control (Disease Control Rate)

Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)\*100.

Time frame:: Baseline to measured PD (up to 29 months)
Reported as:: Number · percentage of participants

Percentage of Participants Achieving Disease Control (Disease Control Rate)
percentage of participants	Ramucirumab and Docetaxel	Placebo and Docetaxel
Percentage of Participants Achieving Disease Control (Disease Control Rate)	64.0 (60.1 to 67.8)	52.6 (48.6 to 56.6)

SecondaryMaximum Improvement on Lung Cancer Symptom Scale (LCSS)

The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.

Time frame:: Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Reported as:: Mean · mm

Maximum Improvement on Lung Cancer Symptom Scale (LCSS)
mm	Ramucirumab and Docetaxel	Placebo and Docetaxel
Loss of Appetite (n=473, 471)	-10.9 ± 26.11	-11.0 ± 26.22
Fatigue (n=473, 472)	-12.1 ± 23.86	-12.0 ± 27.29
Cough (n=476, 473)	-13.8 ± 24.28	-14.3 ± 26.28
Dyspnea (n=472, 477)	-11.0 ± 23.01	-10.5 ± 24.31
Hemoptysis (n=475, 475)	-1.4 ± 8.89	-1.1 ± 8.79
Pain (n=476, 475)	-11.3 ± 23.62	-11.5 ± 24.85
Symptom Distress (n=474, 472)	-10.7 ± 23.37	-12.2 ± 26.25
Interference With Activity Level (n=474, 472)	-8.5 ± 24.13	-7.9 ± 24.95
Global Quality of Life (n=467, 469)	-10.4 ± 22.68	-8.9 ± 23.23
ASBI (n=455, 456)	-6.1 ± 13.75	-6.9 ± 14.50
Total LCSS (n=446, 446)	-5.2 ± 13.75	-6.4 ± 14.66

SecondaryChange From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores

The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time frame:: Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Reported as:: Mean · units on a scale

Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores
units on a scale	Ramucirumab and Docetaxel	Placebo and Docetaxel
Health State Index Score (n=266, 272)	-0.140 ± 0.308	-0.126 ± 0.294
Health State VAS Score (n=272, 254)	-5.9 ± 21.02	-6.1 ± 20.31

SecondaryMaximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab

Time frame:: Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)
Reported as:: Geometric mean · micrograms per milliliter (mcg/mL)

Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab
micrograms per milliliter (mcg/mL)	Ramucirumab and Docetaxel
Cmax at Cycle 3	262 ± 30
Cmin at Cycle 3	28.3 ± 65
Cmax at Cycle 5	237 ± 38
Cmin at Cycle 5	38.4 ± 63

SecondaryNumber of Participants With Anti-Ramucirumab Antibodies

The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.

Time frame:: Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Reported as:: Number · participants

Number of Participants With Anti-Ramucirumab Antibodies
participants	Ramucirumab and Docetaxel	Placebo and Docetaxel
Treatment-Emergent ADA (n=599, 598)	9	16
Follow-Up Emergent ADA (n=506, 481)	9	16

Other pre-specifiedNumber of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died

Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Time frame:: First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Reported as:: Number · participants

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died
participants	Ramucirumab and Docetaxel	Placebo and Docetaxel
At least 1 TEAE	613	594
At least 1 Grade 3, 4, or 5 TEAE	495	444
At least 1 treatment-emergent SAE	269	262
TEAE leading to study drug discontinuation	58	32
TEAE leading to death	34	35
Deaths While On Treatment	428	451
Deaths During 30 Days Post Last Dose	53	58

Adverse events

Collected over Randomization through 30 days following last infusion (up to Cycle 38, 21 days/cycle).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ramucirumab and Docetaxel	—	284/627 (45.3%)	601/627 (95.9%)
Placebo and Docetaxel	—	281/618 (45.5%)	583/618 (94.3%)

Most frequent serious events

Showing 10 of 288

Most frequent serious events
Event	Ramucirumab and Docetaxel	Placebo and Docetaxel
Febrile neutropeniaBlood and lymphatic system disorders	86/627	51/618
PneumoniaInfections and infestations	37/627	41/618
NeutropeniaBlood and lymphatic system disorders	30/627	27/618
DyspnoeaRespiratory, thoracic and mediastinal disorders	11/627	26/618
Pleural effusionRespiratory, thoracic and mediastinal disorders	9/627	21/618
DehydrationMetabolism and nutrition disorders	15/627	15/618
AnaemiaBlood and lymphatic system disorders	10/627	14/618
StomatitisGastrointestinal disorders	14/627	2/618
DiarrhoeaGastrointestinal disorders	13/627	9/618
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	8/627	12/618

Most frequent other events

Showing 10 of 47

Most frequent other events
Event	Ramucirumab and Docetaxel	Placebo and Docetaxel
FatigueGeneral disorders	287/627	260/618
NeutropeniaBlood and lymphatic system disorders	228/627	188/618
DiarrhoeaGastrointestinal disorders	200/627	175/618
Decreased appetiteMetabolism and nutrition disorders	189/627	163/618
AnaemiaBlood and lymphatic system disorders	135/627	174/618
NauseaGastrointestinal disorders	170/627	173/618
AlopeciaSkin and subcutaneous tissue disorders	163/627	156/618
DyspnoeaRespiratory, thoracic and mediastinal disorders	150/627	148/618
StomatitisGastrointestinal disorders	143/627	81/618
CoughRespiratory, thoracic and mediastinal disorders	137/627	131/618

Baseline characteristics

Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization.

Age, Categorical
Age, Categorical(Participants)	Ramucirumab and Docetaxel	Placebo and Docetaxel	Total
<=18 years	0	0	0
Between 18 and 65 years	391	407	798
>=65 years	237	218	455

Sex: Female, Male
Sex: Female, Male(Participants)	Ramucirumab and Docetaxel	Placebo and Docetaxel	Total
Female	209	210	419
Male	419	415	834

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Ramucirumab and Docetaxel	Placebo and Docetaxel	Total
Hispanic or Latino	43	53	96
Not Hispanic or Latino	387	380	767
Unknown or Not Reported	198	192	390

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Ramucirumab and Docetaxel	Placebo and Docetaxel	Total
American Indian or Alaska Native	9	20	29
Asian	74	86	160
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	17	16	33
White	526	503	1029
More than one race	0	0	0
Unknown or Not Reported	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Ramucirumab and Docetaxel	Placebo and Docetaxel	Total
United States	156	152	308
Taiwan	9	18	27
Greece	25	19	44
Spain	27	23	50
Israel	14	8	22
Russian Federation	28	33	61
Italy	26	28	54
Switzerland	12	14	26
India	22	33	55
France	21	24	45
Puerto Rico	1	2	3
Netherlands	15	16	31
Korea, Republic of	34	28	62
Turkey	22	23	45
Austria	11	9	20
United Kingdom	19	19	38
Hungary	9	4	13
Mexico	11	20	31
Canada	12	7	19
Argentina	16	17	33
Brazil	4	3	7
Poland	30	33	63
Romania	41	36	77
Norway	10	3	13
Germany	40	42	82
New Zealand	3	4	7
Sweden	10	7	17

Study locations

231 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona 85016, United States
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Sedona, Arizona 86336, United States
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Fayetteville, Arkansas 72703, United States
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Alhambra, California 91801, United States
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Duarte, California 91010, United States
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Fresno, California 93720, United States
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Fullerton, California 92835, United States
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La Jolla, California 92093, United States
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Long Beach, California 90813, United States
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Los Angeles, California 90095, United States
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Northridge, California 91325, United States
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Redondo Beach, California 90277, United States
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Santa Barbara, California 93105, United States
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Santa Monica, California 93454, United States
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Denver, Colorado 80218, United States
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Waterbury, Connecticut 06708, United States
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Jacksonville, Florida 32204, United States
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Miami, Florida 33176, United States
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Ocala, Florida 34471, United States
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Orlando, Florida 32806, United States
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Athens, Georgia 30607, United States
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Augusta, Georgia 30901, United States
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Lawrenceville, Georgia 30045, United States
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Macon, Georgia 31201, United States
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Rome, Georgia 30165, United States
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Savannah, Georgia 31405, United States
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Springfield, Illinois 62703, United States
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Bloomington, Indiana 47402, United States
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Cedar Rapids, Iowa 52402, United States
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Iowa City, Iowa 52242, United States
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Overland Park, Kansas 66210, United States
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Wichita, Kansas 67214, United States
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Ashland, Kentucky 41101, United States
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Mount Sterling, Kentucky 40353, United States
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Baton Rouge, Louisiana 70809, United States
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Metairie, Louisiana 70006, United States
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Bethesda, Maryland 20817, United States
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Chevy Chase, Maryland 20815, United States
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Boston, Massachusetts 02115, United States
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Danvers, Massachusetts 01923, United States
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Framingham, Massachusetts 01701, United States
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Newton, Massachusetts 02462, United States
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Ann Arbor, Michigan 48109, United States
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Minneapolis, Minnesota 55404, United States
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Columbia, Missouri 65201, United States
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Joplin, Missouri 64804, United States
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Saint Louis, Missouri 63110, United States
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Billings, Montana 59101, United States
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Henderson, Nevada 89169, United States
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Reno, Nevada 89502, United States
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Lebanon, New Hampshire 03756, United States
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Portsmouth, New Hampshire 03801, United States
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Albuquerque, New Mexico 87109, United States
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Bronx, New York 10467, United States
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Latham, New York 12110, United States
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New York, New York 10021, United States
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Durham, North Carolina 27704, United States
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Raleigh, North Carolina 27607, United States
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Fargo, North Dakota 58122, United States
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Columbus, Ohio 43219, United States
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Tulsa, Oklahoma 74136, United States
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Abington, Pennsylvania 19001, United States
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Kingston, Pennsylvania 18704, United States
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Philadelphia, Pennsylvania 19106, United States
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Charleston, South Carolina 29414, United States
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Sioux Falls, South Dakota 57104, United States
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Chattanooga, Tennessee 37403, United States
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Memphis, Tennessee 38138, United States
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Abilene, Texas 79606, United States
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Amarillo, Texas 79106, United States
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Beaumont, Texas 77702, United States
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Bedford, Texas 76022, United States
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Dallas, Texas 75231, United States
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El Paso, Texas 79915, United States
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Fort Worth, Texas 76104, United States
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Lewisville, Texas 75067, United States
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McAllen, Texas 78503, United States
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Mesquite, Texas 75150, United States
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Midland, Texas 79701, United States
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Odessa, Texas 79761, United States
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Paris, Texas 75460, United States
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San Antonio, Texas 78212, United States
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San Antonio, Texas 78229, United States
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Sherman, Texas 75090, United States
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Sugar Land, Texas 77479, United States
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The Woodlands, Texas 77380, United States
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Tyler, Texas 75702, United States
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Webster, Texas 77598, United States
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Wichita Falls, Texas 76310, United States
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Christiansburg, Virginia 24073, United States
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Fairfax, Virginia 22031, United States
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Newport News, Virginia 23601, United States
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Richmond, Virginia 23298, United States
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Lacey, Washington 98503, United States
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Spokane, Washington 99216, United States
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Wenatchee, Washington 98801, United States
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Madison, Wisconsin 53705, United States
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Buenos Aires, C1417EYG, Argentina
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Córdoba, X5016KEH, Argentina
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La Rioja, 5300, Argentina

Showing the first 100 of 231 sites across 27 countries.

References and documents

Publications

Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2. PubMed 35930972 ↗
Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Perol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1):e000567. doi: 10.1136/esmoopen-2019-000567. PubMed 31958290 ↗
Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2. PubMed 24933332 ↗
Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31. PubMed 22853980 ↗

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01168973
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Jul 23, 2010
Start date: Dec 2010
Primary completion: Dec 2013
Completion: Aug 2016
Results posted: Dec 29, 2014
Last update: Sep 25, 2019

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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